Labiotech.eu’s Post

The increasing importance of #clinicaltrials for #biologicdrugs has led to a growing need for ultra-frozen capabilities among our clients. To meet this demand, we have invested in new ultra-low freezers at our clinical trial services facility in #Incheon, Korea. This investment ensures that we can offer enhanced services that help bring #largemolecules to market. This expansion of our capabilities includes the introduction of #goodmanufacturingpractice (GMP) storage at deep frozen temperatures (-60°C to -80°C and -70°C to -90°C). This addition complements our existing capacity for #GMP storage across various conditions, including controlled ambient (15°C to 25°C), refrigerated (2°C to 8°C), and frozen (-15°C to -25°C). To learn more about our end-to-end #CDMO capabilities in #Incheon, click here: http://spr.ly/6045dwGox

Thoughts on this? >> J&J cements footprint in Italy with €580M in investments over the next 5 years >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #productmarketing #healthcare #biotech

The path to IVD registration in Japan can be complex, but understanding the key processes under the PMDA is critical for success. From classifying IVDs based on risk levels to navigating pre-market notifications, certifications, and approvals, compliance is essential to ensure your products meet Japan's high healthcare standards. Looking to bring your diagnostic products to Japan? Make sure you’re well-versed in the regulatory framework! Check out our infographic for a detailed overview: https://shorturl.at/q4N2N #MedicalDevices #PMDA #InvitroDiagnostics #Japan #regulatoryPathway #Freyr #FreyrMedicalDevices 

9 days to go! Want to get a solid understanding of the challenges clinical sites experience when using IRT systems and how to mitigate for these when selecting your system? Join us next week in Boston where Joe Lisi, Senior Manager, Clinical Information Operations, IRT Lead at Takeda will be moderating a discussion with Igor Druker, Director, IRT & Clinical Supply Systems at Biohaven Pharmaceuticals and Jimmy Bechtel, MBA, Vice President, Site Engagement at Society for Clinical Research Sites (SCRS), diving into “Pain Points for Sites when Using IRT Systems" addressing these big questions: - What in IRT systems is redundant from a site perspective? - What processes are helping or hindering them? - What is IRT’s role in making things easier for sites? - What are support sites wants and needs from sponsors and vendors? - What are the wants and needs with regards to data exchange? Join them to understand the various challenges and implement your learnings to ensure you're supply strategy is running as quickly and effectively as possible from the get-go! 👉 Register now: https://lnkd.in/ecrmZS8z 📑 Download the agenda to learn more: https://lnkd.in/eTbas2UG #IRT2024 #IRT #InteractiveResponseTechnologies #ClinicalSite #ClinicalResearchSite #ClinicalSupply #ClinicalSystems #ClinicalTechnology #ClinicalResearch #Pharmaceuticals #Biotech

On July 22, 2024, the European Commission made commitments offered by Vifor legally binding under EU antitrust rules. These commitments address the Commission's concerns regarding Vifor's potential disparagement of Monofer, a competitor to Vifor's flagship intravenous iron medicine, Ferinject. Commission's Concerns: - Vifor may be dominant in national markets for intravenous iron medicines in several countries, including Austria, Finland, Germany, Ireland, Portugal, Romania, Spain, Sweden, and the Netherlands. - Vifor allegedly disseminated misleading information about Monofer’s safety, hindering its uptake in the European Economic Area (EEA). - This conduct may constitute an abuse of dominant position, violating Article 102 of the Treaty on the Functioning of the European Union (TFEU). Commitments by Vifor: 1. Communication Campaign: - Launch a multi-channel campaign to rectify and undo misleading messages about Monofer. - Disseminate factual communications via email, mail, in-person meetings, websites, and leading medical journals. - Allow third parties, including Pharmacosmos, to use these communications when contacting healthcare professionals. 2. Promotion and Communication Restrictions: - Avoid external promotional or medical communications about Monofer's safety unless based on Monofer's label or derived from comparative clinical trials. 3. Compliance Measures: - Implement internal mechanisms to ensure all promotional and medical communications align with the commitments. - Conduct annual internal training and certification of compliance. Background: 1. Investigation History: - The Commission opened a formal antitrust investigation in June 2022 following a complaint by Pharmacosmos. - In February 2024, Vifor and Pharmacosmos reached a confidential commercial settlement. - The Commission adopted a Preliminary Assessment in April 2024, identifying preliminary competition concerns. 2. Regulatory Framework: - Article 102 of the TFEU prohibits abuse of a dominant position that restricts competition. - Regulation No 1/2003 allows companies to offer commitments to address the Commission's concerns, making them legally binding. - Failure to comply with commitments can result in significant fines. Impact: The commitments aim to restore fair competition in the market for intravenous iron medicines and ensure that healthcare professionals receive accurate information. The implementation of these commitments will be monitored by a trustee for a period of 10 years. Stay informed on the latest antitrust developments with Global Regulatory Insights! #Antitrust #Pharmaceuticals #Vifor #EURegulations #GRI

We are proud to announce that Biomedical Advanced Research and Development Authority (BARDA) has selected Kaléo to develop the next generation pralidoxime chloride (2-PAM) auto-injector as a medical countermeasure against nerve agent poisoning. “The contract tasks Kaléo with developing a 2-PAM auto-injector for U.S. Food and Drug Administration (FDA) approval within 3 years, with an ultimate goal of enabling later procurement of the 2-PAM auto-injectors for BARDA’s CHEMPACK program,” said Mark Herzog, Kaleo’s VP for Global Corporate Affairs, Defense and Homeland Security. Kaléo is a market leader in emergency use auto-injectors with more than 12 million devices manufactured to meet the FDA’s standard of 99.999% device reliability. Read our full announcement here: https://bit.ly/2PAM_AI #Kaleo #MCM #medicalcountermeasure #CHEMPACK #BARDA #publichealth

Ukraine goes eCTD – learn more in our exclusive webinar! Join us on 16 May 2024, at 09:00 CEST for our webinar "eCTD Essentials: A Comprehensive Overview for Ukraine's Pharma Industry." Use this opportunity to stay ahead of the curve and register now: https://lnkd.in/dNZNbSsX. We've teamed up with Medicines for Europe to bring you this event specially designed to guide Ukraine's pharma industry through the eCTD landscape and provide practical insights. What to expect: - Understanding eCTD: Dive deep into technical aspects and valuable tips for submission preparation. - Expert Guidance: Michael Faust - Business Consultant for Regulatory Affairs guides you towards eCTD, offering actionable advice plus a live software demo by Maren Müller. We are also honored to welcome guests from the responsible authorities and present the general information partner of the event—"PHARMACY Weekly," a Ukrainian specialized magazine for healthcare professionals. Find more information here: https://lnkd.in/daGHCcsT or follow Apteka on LinkedIn: https://lnkd.in/dgs9B22V. A big THANK YOU to our valuable partner in Ukraine, DataMind Global, who will support us with their expertise and translation! Can't make it? No problem! Register anyway for access to the recording. #EXTEDO #eCTD #Ukraine #MedicinesForEurope #DataMindGlobal #Apteka

Thoughts on this? >> J&J cements footprint in Italy with €580M in investments over the next 5 years >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharma #biotech #healthcare #pharmaceutical

There are several precautions regarding service partnerships with China mentioned in this article. However, one bright spot is partnerships via product commercialization in China. “China’s market continues to be attractive, and the majority of biopharmas wish to consider commercialization,” the report said. “Collaboration with Chinese service providers in clinical research, development and manufacturing is also not completely off the table, with approximately 30% of respondents considering these partnerships as likely in the next three years." #biosecureact #industryadjustments #biopharma #cdmo #cro #commercialization #research #outsourcing

🔬🇺🇦 Ukraine was once the burgeoning hub for clinical trials in the pharmaceutical industry. As the war persists, the impact on the sector has been severe, with trials significantly reduced from pre-war levels. What does the future hold for clinical trials in Ukraine? Read more about the ongoing situation and its effects on the industry.